As More Imported Foods Reach the Dinner Table, Holes Remain in the FDA Safety Net

(This report by Rick Schmitt was first published June 26, 2014, by FairWarning, a Los Angeles-based nonprofit news organization focused on public health, safety and environmental issues, and related topics of government and business accountability.)

In April 2012, a team of inspectors from the U.S. Food and Drug Administration (FDA) investigated a seafood company in southern India that had been exporting tons of frozen yellow fin tuna to the United States. What they found was not appetizing: water tanks rife with microbiological contamination, rusty carving knives, peeling paint above the work area, unsanitary bathrooms and an ice machine covered with insects and “apparent bird feces,” according to the report.

FDA issued an “import alert” that barred Moon Fishery India Pvt. Ltd. from shipping fish to the U.S. But the damage to public health had been done. By the time FDA got around to inspecting the plant, a Salmonella outbreak was erupting around the country. Ultimately, 425 people in 28 states and the District of Columbia were sickened, with victims ranging from babies to octogenarians. According to the Centers for Disease Control and Prevention (CDC), 55 people were hospitalized.

The fact that tons of bad fish had sailed into this country was not a surprise. FDA has been outgunned and overmatched for years as a rising tide of imported food has found a place at the U.S. dinner table. Because of budget constraints, ordinarily only 1 to 2 percent of food imports are physically inspected by the agency at the border each year. Typically, operations such as the one in India are inspected only if something goes terribly wrong.

And the threat of illness from imports may be growing. According to an analysis of FDA data by FairWarning and the Investigative News Network (INN), FDA today rejects about the same number of shipments of foreign food as it did a decade ago — when imports were less than half the current level.

The violations that FDA inspectors are finding pose some serious health risks. According to the analysis by FairWarning and INN, some 16,700 shipments of imported foods were barred over the past decade because they included a “filthy, putrid, or decomposed substance” or were “otherwise unfit for food.” That was the leading reason imports were rejected. According to FDA records, foods rejected in 2013 included hard candy from Mexico deemed “filthy” or “poisonous,” Salmonella-infected cumin and ginger from India, and fish from Vietnam with excessive levels of histamine.

William Hubbard

FDA declined to make officials available to comment for this story, either on background or on the record. The agency also refused a request by FairWarning to accompany inspectors at a port of entry. In response to questions, an FDA spokeswoman provided publicly available links to the agency website, previously issued press releases and congressional testimony by agency officials. While acknowledging gaps, the agency says technology, including a new computer system, is helping inspectors zero in on some of the worst offenders.

Imports were supposed to face tighter scrutiny by now. In January 2011, President Obama signed into law a bipartisan overhaul of the way FDA regulates imported and domestically produced foods, known as the Food Safety Modernization Act. But outsized hopes for the law have gone unfulfilled because of agency foot-dragging, flagging interest in Congress for public funding, and food industry opposition to proposed user fees to finance the reform.

Smorgasbord of Tainted Food

At least eight foodborne illness outbreaks — tied to hundreds of illnesses, hospitalizations and deaths — have occurred since the law was passed. The smorgasbord of tainted foods includes a brand of ricotta cheese from Italy that was linked in 2012 to a multi-state outbreak of Listeriosis, a bacterial infection. Among the victims: a California woman, 27 weeks pregnant, who gave birth prematurely after eating some of the cheese. Her child tested positive for Listeria and later died.

That adds to an already large toll of food poisoning victims. CDC estimates that one in six Americans suffers from a foodborne illness each year, with children, the elderly and the infirm suffering disproportionately. Economic costs of disease outbreaks to consumers, farmers and food processors are huge — more than $100 billion a year, according to one estimate.

“They look at very, very little. They sample very, very little. There is a risky environment out there for food because FDA is so weak,” says William Hubbard, a former FDA senior associate commissioner who is now a consultant. “It is still a little bit of an honor system.”

Carl Nielsen, a former director of FDA’s import operations who has testified before Congress about gaps in monitoring imports, says nothing has changed for years. “It is the same system. It is the same lack of resources. It is a huge, huge problem,” he said.

To be sure, some of the worst cases of illness in recent years have involved home-grown foods. Some three dozen people died in 2011 after eating cantaloupe from a farm in Colorado. Three officials of a Virginia peanut company are scheduled to stand trial this summer on fraud and conspiracy charges in connection with a Salmonella outbreak that killed nine people and sickened 700.

But rising imports have brought rising concern.

“It is important to note that while FDA is not able to physically inspect a large percentage of food entries, all import entries are electronically screened using an automated system, which helps field inspectors determine which products pose the greatest risk and, therefore, should be physically examined.” — FDA, in a 2013 report to Congress.

Stepchild of Food Safety

About 15 percent of the food that Americans now consume is imported, including about half the fruits and vegetables in the winter and most seafood throughout the year. Virtually all spices and many ingredients in processed foods come from abroad. FDA-regulated imports originate from an estimated 130,000 facilities worldwide in 150 countries, a daunting number to oversee even under the best of circumstances.

FDA has been a stepchild of federal food safety. It is responsible for 80 percent of the U.S. food supply, including imports, but its resources are dwarfed by those of the Food Safety and Inspection Service, an arm of the Agriculture Department, which regulates meat, poultry and eggs.

The Food Safety Modernization Act called for a big increase in FDA inspection staff and set bold new goals for preventing contamination at foreign food plants. Under the law, private auditors are to certify that foreign plants meet federal standards, complementing the work of FDA inspectors. Importers, for the first time, will have to vouch for the manufacturing practices of the suppliers they do business with overseas. With bipartisan support, the law was hailed as a milestone, one of the most significant changes in food regulation since Upton Sinclair’s “The Jungle” exposed sordid conditions in the meatpacking industry at the turn of the last century, triggering the first federal food laws.

Today, key regulations covering imports called for under the new law have not been implemented, and the agency is under a consent order to pick up the pace, following a lawsuit by a public-interest group. FDA is far behind in meeting other mandates, too. The law requires the agency to inspect 19,200 foreign plants by the 2016 fiscal year. In 2012 — the latest year for which data are available — the agency had inspected just 1,342 plants, with little hope of much growth anytime soon. “Reaching the goal of 19,200 foreign inspections called for by FSMA,” FDA wrote in a report to Congress last year, “would require hundreds of millions of dollars in new funding which the agency cannot realistically expect to receive.”

Congress has shown little appetite for supplying those funds. “This is mindless, what is happening,” said Rep. Rosa DeLauro (D-CT), a lead sponsor of the food safety legislation. “We need to provide the money to FDA so we can protect people.”

The idea that imported foods are available for consumption without ever being inspected, at the source or at the border, surprises and unnerves many Americans.

Sheila Lewis

Sheila Lewis, a Virginia-based auto broker, was one of the 425 people who got Salmonella poisoning after eating tuna from Moon Fishery, the Indian business that became the target of an FDA “import alert.” She was on a buying trip to Pennsylvania in March 2012 when she capped off a day of shopping with a meal at a favorite sushi bar where she ordered the spicy tuna roll.

When Lewis started feeling ill, she thought it was related to the fact that she suffers from Crohn’s disease, an inflammatory bowel disorder, so she did not immediately seek medical treatment. Doctors later told her that the wait almost killed her. Her suffering from Crohn’s has since become more acute, which she suspects is related to the tuna poisoning.

Team Dispatched to India

Federal authorities traced the outbreak to four restaurants in the U.S. that had bought tuna “scrape” — so-named because it is scraped from the bones after fish is filleted — from Moon Fishery. FDA immediately sent a team to inspect the plant in Kerala and issued the order blocking further imports the day the inspection was completed.

Lewis is unsettled by the timing and the discovery of decrepit and unsanitary conditions.

“That is not something that happens overnight. How often was this facility being monitored?” she says. “After several hundred people have been sickened and hospitalized, now we go out and check what their facility looks like? That is such crap.”

Since 2007, Moon had sent about 150 shipments of tuna into the U.S.; it is unclear how much, if any, was inspected. According to the records, four shipments of the “scrape” came through the port of New York in early 2012, including one in March when Lewis and others got sick. Four shipments in May — after the FDA import alert — were rejected for Salmonella, including shipments of tuna loin and “scrape.”

FDA declined to comment on the inspection history of the tuna and the plant in India. In a report last year, the agency highlighted the tuna case as a “landmark” example of interagency cooperation in tracing the cause of an outbreak.

The gatekeepers in this system are FDA entry reviewers who are stationed at ports of entry and use computers to track and decide the fate of hundreds of scheduled shipments from abroad each day.

When they make the rare decision to inspect cargo, they take into account the food and region of origin as well as the history of the manufacturer and importer. A software program FDA calls PREDICT (Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting) gathers the data and scores each shipment.

FDA also bars products through import alerts, which put importers on notice that their products will be detained and warehoused until they can prove them safe. FDA manages scores of food-related import alerts, some of which have been outstanding for years, covering everything from Basmati rice from India to frog legs from Bangladesh.

But the number of import refusals, as a barometer of the system, has remained generally unchanged for a decade, even as the volume of imports has greatly increased. According to the analysis by FairWarning and INN, the refusal rate in 2012 was just over half the rate of 2002.

Seeking a Technological Fix

FDA acknowledges the limits of its inspection program but believes that its new technology has improved its ability to target suspect foods.

“It is important to note that while FDA is not able to physically inspect a large percentage of food entries, all import entries are electronically screened using an automated system, which helps field inspectors determine which products pose the greatest risk and, therefore, should be physically examined,” the agency said in a report to Congress last year.

Yet FDA apparently has no idea of the scale of the risk from imported foods. Consumer groups have pushed the agency for years to determine how many inspections it would take to intercept most problem foods. Critics say the process has been driven by available resources rather than science.

“They just do a back of the envelope calculation,” said David Plunkett, senior staff attorney for the food safety program at the Washington, D.C.-based Center for Science in the Public Interest. “Shouldn’t you be able to put together a program that says if we sample ‘X percent’ we have a 90-percent chance of catching most of the problems out there? We don’t do that.”

One of the things that FDA inspectors missed last year was a shipment of pomegranate seeds from Turkey. The shipper, Goknur Foodstuffs Import Export Trading, an Ankara-based grower and processor of fruits and fruit juices, had previously sent lots of fruit to the U.S. without incident. But a few episodes had raised red flags.

Shipments Turned Back

According to the review of import data by FairWarning and INN, a shipment of apple juice concentrate from Goknur was rejected by FDA at the port of San Francisco in 2004 due to fear it was tainted by mycotoxin, a highly toxic mold. Another Goknur shipment was turned back in 2010 because a fruit container appeared to be made of a “poisonous” or other hazardous substance. Four shipments in 2011 were rejected for failing to accurately list ingredients.

Michael Walters

Last year, CDC blamed pomegranate seeds from Goknur for an outbreak of Hepatitis A that sickened 162 people in 10 states. The seeds were used by other companies to make organic fruit drinks.

FDA declined to discuss its handling of the case, but experts say the prior problems with Goknur should have made inspectors more vigilant.

“The history of a line is extremely important,” said Dean Cook, a retired former supervisory inspector for FDA at the port of Baltimore.

“The fact that the manufacturer was negligent in one area kind of bleeds over into his disregard in other areas,” Cook said. “The question here is whether the entry reviewer was aware of the past violation. A lot of it goes back to resources.”

Goknur, in court papers filed in response to personal injury claims, has denied that the seeds caused the Hepatitis outbreak. An attorney for the company in the U.S. said she was unable to comment.

In a news release last year announcing import restrictions on the pomegranate seeds, Michael R. Taylor, FDA’s deputy commissioner for foods and veterinary medicine, said: “The Hepatitis A outbreak shows how we have improved our ability to investigate and respond to outbreaks, but also why we are working to build a food safety system that more effectively prevents them.”

Last May, Michael Walters, a youth detention center worker in Colorado, was among those who got sick from the pomegranate seeds. They were an ingredient in an antioxidant fruit mix he bought at Costco, which he used for smoothies and health drinks.

“I was loading up twice a day with this stuff, trying to promote good, vigorous heart health,” says Walters, 61, who had recently undergone quadruple heart bypass surgery.

On vacation with his wife in Yellowstone National Park to celebrate their 25th wedding anniversary, Walters began to feel tired, feverish and nauseous. At first, he thought it might be his heart. His daughter made the connection with the berry mix when she noticed a recall notice on the Costco website. Walters was later diagnosed with Hepatitis A and was hospitalized because his doctors were worried about his liver shutting down. Six months later, he says, he was able to return to work.

Walters was one of eight consumers sickened by imports who testified at an FDA hearing last fall on stalled regulations called for by the new food safety law. Walters appreciated the opportunity to speak but could not help notice that the room was crowded with food industry representatives. He worries about how their influence will shape the process going forward. He also worries how consumers are supposed to protect themselves, given that imports have become an everyday staple. He is trying to have some faith in the system and is hoping for the best.

“Overall, it’s just really set us back at a time in life when you’re supposed to be reaping the benefits of 45 years of work,” he testified at the FDA hearing. “I urge you all to continue on this path with the food modernization act and implement it and enforce it as quickly as you can … to prevent this kind of affair from having other people suffer as we have.”

Denise Malan of the Investigative News Network contributed to this report.